Endometrin Insert
FDA Recall NDC 55566-6500
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Endometrin (NDC 55566-6500). A significant event, classified as Class III, was initiated on Sep 19, 2013 by Ferring Pharmaceuticals Inc.. The reported reason for this action was: "Discoloration; due to prolonged heat exposure."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
September 2013 Class III Recall: Discoloration; due to prolonged heat exposure.
Recall Number
Class III Terminated
Discoloration; due to prolonged heat exposure.
Sep 19, 2013
Jul 16, 2014
72,046 cartons
Recall Profile & Regulatory Data
Event ID
66604
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Ferring Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Feb 19, 2015
Product Description
ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3
Batch or Lot Expiration Information
Lot# Lot Number:Expiry Date - 0804.182B-1:07/14; 0804.183B-1:07/14; 0804.185A-1:08/14; 0804.186B-1:08/14; 0804.187B-1:08/14; 0804.210A-1:12/14; 0804.212A-1:12/14; 0804.213A-1:12/14; 0804.214A-1:12/14; 0804.216B-1:12/14; 0804.223B-1:02/15 0804.225B-1:03/15
Affected Packages Involved in this Recall
55566-6500-1Product
55566-6500-2Product
55566-6500-3Product
55566-6500-4Product
55566-6500-7Product
55566-6500-8Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
